Acetaminophen and Codeine Phosphate

Product NDC

68788-9736

11-digit product format

687889736

Labeler code

68788

Product ID

68788-9736_b5dc7184-7f41-49c0-b0c2-7c075988c224

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Acetaminophen and Codeine Phosphate

Dosage form

TABLET

Route

ORAL

Labeler

Preferred Pharmaceuticals Inc.

Application

ANDA088629

Marketing category

ANDA

Marketing start

2015-08-20

Marketing end

0000-00-00

Substance

ACETAMINOPHEN; CODEINE PHOSPHATE

Active strength

300 mg/1; mg/1

Pharmacologic classes

Full Opioid Agonists [MoA],Opioid Agonist [EPC]

DEA schedule

CIII

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record